Clinical Observation on the Efficacy of Patient-Donor Derived Probiotics in Improving Intestinal Flora Disorder in Patients With Intestinal Acute Graft-Versus-Host Disease (aGVHD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Clinical response rate of intestinal acute graft-versus-host disease (aGVHD)
研究概览
简要总结
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
详细描述
Study Design Overview:
Ten patients aged >50 years scheduled for haploidentical hematopoietic stem cell transplantation (HSCT) will be enrolled. Stool specimens will be collected from both patients and donors (due to frequent depletion of beneficial bacteria in such patients, donor specimens are essential to enhance probiotic detection and cultivation rates). Patient specimens will undergo 16S rDNA intestinal microbiome analysis.
Upon clinical diagnosis of intestinal aGVHD:
- Pre-collected patient and donor specimens will be homogenized
- Target isolation and culture of core beneficial bacteria (Lactobacillus and Bifidobacterium)
- Strain identification via TOF mass spectrometry
- Fermentation and preparation of 200 enteric-coated capsules (100 Lactobacillus capsules + 100 Bifidobacterium capsules)
Post-intervention assessment (100 days after administration):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects eligible for this study must satisfy all of the following criteria:
- •Age >50 years, regardless of gender;
- •Scheduled for haploidentical hematopoietic stem cell transplantation;
- •ECOG performance status score ≤2;
- •Voluntarily participate and provide written informed consent.
排除标准
- •Subjects presenting with any of the following conditions will be excluded from this study:
- •Active or chronic infectious diseases, including recent febrile symptoms (axillary temperature ≥37.3°C within 48h);
- •Gastrointestinal disorders:
- •Clostridioides difficile infection (CDI): Recurrent or refractory CDI;
- •Other conditions: Ulcerative colitis, Crohn's disease, irritable bowel syndrome (IBS), diarrhea associated with dysbiosis, liver cirrhosis;
- •Allergic or immune-mediated diseases:
- •Autoimmune hepatitis, systemic lupus erythematosus (SLE), ankylosing spondylitis, immune-mediated osteoarthritis, allergic dermatitis, immune thrombocytopenic purpura (ITP);
- •Antibiotic usage within 7 days prior to enrollment.
研究组 & 干预措施
Patient-Donor Derived Probiotics
To clinically evaluate the efficacy of patient- and/or donor-derived probiotics in ameliorating intestinal flora dysbiosis in patients with acute intestinal graft-versus-host disease (aGVHD), thereby mechanistically enhancing clinical outcomes and quality of life through intestinal microbiome modulation.
干预措施: Patient-Donor Derived Probiotics (Drug)
结局指标
主要结局
Clinical response rate of intestinal acute graft-versus-host disease (aGVHD)
时间窗: within 100 days
Changes of stool frequency of subjects before and after taking probiotic capsules from patients.
次要结局
- To study the changes of intestinal flora of subjects before and after taking probiotics from patients for 100 days(within 100 days)